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BeOne Medicines
BeOne Medicines
BiotechnologyHealthcarePharmaceuticals
BeOne Medicines is a Switzerland-domiciled global oncology company focused on discovering and developing innovative cancer treatments designed to improve affordability and access. Its portfolio covers hematologic cancers and solid tumors, supported by an expanding pipeline of novel therapeutics advanced through in-house capabilities and external collaborations. With more than 11,000 colleagues across six continents, BeOne Medicines is working to broaden access to medicines for patients worldwide.
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Regional Clinical Study Manager - United States Remote

Lead regional oncology clinical trial delivery for BeOne Medicines, coordinating operations, vendors, timelines, budgets, quality, and regulatory execution across assigned countries.

USUnited States
$118,600 – $158,600 / year
RemoteFull-timeMiddleSeniorEnglish RequiredClinical Research
Google Cloud Platform

Description

  • Own regional study delivery while maintaining inspection-ready quality, approved timelines, and budget performance
  • Lead the regional clinical operations team and manage external regional partners
  • Serve as the escalation contact for regional study issues
  • Keep regional deliverables aligned with overall study objectives
  • Chair regional operations meetings and represent the regional study team in internal and cross-functional forums
  • Plan and manage assigned clinical studies from feasibility through regional closeout
  • Create, manage, and maintain regional start-up and recruitment timelines
  • Direct trial feasibility, country allocation, and site selection with relevant stakeholders
  • Contribute regional perspectives to global study plans
  • Coordinate local adaptations of global study documents and support timely regulatory and EC/IRB submissions
  • Ensure study submissions are completed in assigned countries with study start-up and regulatory teams
  • Maintain regional and country data in study systems and related tools
  • Partner with CRAs on site execution and review and approve monitoring reports
  • Ensure country- and site-level Trial Master Files are established, maintained, and quality-checked
  • Advise on regional drug inventories, local labeling, comparator approvals, and reimbursement status
  • Oversee regional trial data collection, data entry, and query resolution
  • Support Clinical Study Report planning and delivery
  • Resolve escalated site issues and monitor adherence to protocols, SOPs, ICH/GCP, and applicable regulations
  • Maintain regional inspection readiness and implement solutions to study issues
  • Prepare sites for audits and inspections and lead responses to findings
  • Distribute lessons learned and effective practices across teams
  • Lead process improvements and contribute to work instructions and SOPs
  • Select and manage regional study vendors in partnership with sourcing
  • Control regional study budgets
  • Coordinate investigator fees, site payments, and patient travel reimbursements
  • Identify regional staffing needs and contingency plans
  • Track regional resource utilization
  • Provide performance feedback and mentor junior team members when needed

Requirements

  • At least four years of progressive clinical research experience in biotechnology, pharmaceuticals, or a CRO
  • Demonstrated clinical research experience, including team leadership in clinical functions
  • CRA experience is preferred
  • A bachelor's degree in a scientific or healthcare field is required; an advanced degree is preferred
  • Relevant clinical operations experience may be considered in place of the stated degree requirement
  • Proficiency with Microsoft Office
  • Proficiency with project planning applications
  • Working knowledge of clinical study delivery, clinical operations, study start-up, recruitment, feasibility, country allocation, site selection, regulatory submissions, TMF management, data collection, query resolution, ICH/GCP, SOPs, and applicable regulations
  • Willingness to travel as business needs require

Benefits

  • Eligibility for an annual bonus plan in non-commercial roles
  • Eligibility for an incentive compensation plan in commercial roles
  • Discretionary equity award opportunities
  • Employee Stock Purchase Plan
  • Medical insurance coverage
  • Dental insurance coverage
  • Vision insurance coverage
  • 401(k) retirement plan
  • Flexible Spending Account and Health Savings Account options
  • Life insurance
  • Paid time off
  • Wellness benefits
  • Reasonable accommodations for applicants with disabilities

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